Freeze Away Dual Action 8ct

GUDID 00888853002958

Combination Cryogenic and Liquid Wart Remover

SCHOLL'S WELLNESS COMPANY LLC

Wart-removal cryogenic kit
Primary Device ID00888853002958
NIH Device Record Key8ec3cc74-1763-4871-bad1-68986521ab6a
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeze Away Dual Action 8ct
Version Model Number90000336
Company DUNS117174744
Company NameSCHOLL'S WELLNESS COMPANY LLC
Device Count8
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com
Phone19738015515
Emailalex.terranova@drscholls.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 68 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100888853002958 [Unit of Use]
GS110888853002955 [Primary]

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-20
Device Publish Date2022-07-12